Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for PD
1 other identifier
interventional
20
1 country
1
Brief Summary
Speech disorders affect more than 90% of patients with Parkinson's disease (PD). Neither of conventional drugs nor surgery can effectively improve speech function. Western speech rehabilitation is effective for speech disorders, but the domestic use of those methods used is limited. Our preliminary results revealed that traditional Chinese Yi jin jing tiger roaring speech rehabilitation is effectively in the treatment of speech disorders in PD, however, high-quality clinical evidence is still scarce. In order to solve this problem, we will conduct a prospective cohort study to explore the effects of Yi Jin Jing tiger roaring speech rehabilitation with real-time feedback technique on speech disorders in PD patients. This study will help to establish a set of Chinese Medicine treatment and objective evaluation methods for PD speech disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedAugust 27, 2020
August 1, 2020
2.2 years
August 22, 2020
August 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states
The Voice Handicap Index is a self-administered instrument, comprising 30 items on voice-related dysfunction. VHI has a range of 0 (normal voice function) to 120 (severe voice dysfunction).
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary Outcomes (7)
Differences in voice parameters between treatment conditions in the on- and off- medication states
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Differences in Beck Depression Inventory (BDI) scores between Treatment conditions.
Baseline, 4 weeks
- +2 more secondary outcomes
Study Arms (2)
Yi Jin Jing Tiger Roaring Speech Rehabilitation
EXPERIMENTALYi Jin Jing tiger roaring speech rehabilitation with real-time feedback technique Duration: Each time requires an hour of training; Frequency: three times a week, 4 weeks in total.
Conventional Speech Rehabilitation
EXPERIMENTALPatients will receive speech rehabilitation recommended by The Parkinson's Foundation. Duration: Each time requires an hour of training; Frequency: three times a week, 4 weeks in total.
Interventions
A traditional Chinese medicine treatment
A active speech rehabilitation method recommended by the Parkinson's Foundation of America
Eligibility Criteria
You may qualify if:
- Patients with idiopathic Parkinson's disease
- Native language is Chinese
- VHI-10 score more than 10
- informed consent
You may not qualify if:
- Previous or concurrent medical history affecting swallowing function (laryngeal diseases such as vocal nodules, gastroesophageal reflux, and laryngeal cancer).
- History of serious psychosis
- Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
- Dementia (A Mini-Mental State Examination (MMSE) score of \< 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
- Lack of cooperation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
August 22, 2020
First Posted
August 27, 2020
Study Start
October 1, 2020
Primary Completion
December 31, 2022
Study Completion
September 30, 2023
Last Updated
August 27, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share